Sinus Dilation Catheter

ABSTRACT

A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess or maxillary sinus) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

RELATED APPLICATIONS

This Application is a continuation of U.S. patent application Ser. No.16/393,594, filed Apr. 24, 2019, which is a continuation of U.S. patentapplication Ser. No. 15/290,930, filed Oct. 11, 2016, which is acontinuation of U.S. patent application Ser. No. 13/535,076, filed Jun.27, 2012, which claims priority to U.S. Provisional Patent ApplicationNo. 61/502,699 filed on Jun. 29, 2011, the contents of which are herebyincorporated by reference in their entirety.

FIELD OF THE INVENTION

The field of the invention generally relates to balloon inflationdevices and methods. More particularly, the field of the inventionrelates to balloon dilation devices and methods for the treatment ofsinusitis.

BACKGROUND OF THE INVENTION

Sinusitis is a condition affecting over 35 million Americans, andsimilarly large populations in the rest of the developed world.Sinusitis occurs when one or more of the four paired sinus cavities(i.e., maxillary, ethmoid, frontal, sphenoid) becomes obstructed, orotherwise has compromised drainage. Normally the sinus cavities, each ofwhich are lined by mucosa, produce mucous which is then moved by beatingcilia from the sinus cavity out to the nasal cavity and down the throat.The combined sinuses produce approximately one liter of mucous daily, sothe effective transport of this mucous is important to sinus health.

Each sinus cavity has a drainage pathway or outflow tract opening intothe nasal passage. This drainage passageway can include an ostium, aswell as a “transition space” in the region of the ostia, such as the“frontal recess,” in the case of the frontal sinus, or an “ethmoidalinfundibulum,” in the case of the maxillary sinus. When the mucosa ofone or more of the ostia or regions near the ostia become inflamed, theegress of mucous is interrupted, setting the stage for an infectionand/or inflammation of the sinus cavity, i.e., sinusitis. Though manyinstances of sinusitis may be treatable with appropriate medicates, insome cases sinusitis persists for months or more, a condition calledchronic sinusitis, and may not respond to medical therapy. Some patientsare also prone to multiple episodes of sinusitis in a given period oftime, a condition called recurrent sinusitis.

Balloon dilation has been applied to treat constricted sinus passagewaysfor the treatment of sinusitis. These balloon dilation devices typicallyinvolve the use of an inflatable balloon located at the distal end of acatheter such as a balloon catheter. Generally, the inflatable balloonis inserted into the constricted sinus passageway in a deflated state.The balloon is then expanded to open or reduce the degree ofconstriction in the sinus passageway being treated to facilitate bettersinus drainage and ventilation. At the same time most, if not all, ofthe functional mucosal tissue lining of the sinuses and their drainagepassageways are preserved.

Exemplary devices and methods particularly suited for the dilation ofanatomic structures associated with the maxillary and anterior ethmoidsinuses are disclosed, for example, in U.S. Pat. No. 7,520,876 and U.S.Patent Application Publication No. 2008-0172033. Other systems have beendescribed for the treatment of various other sinuses including thefrontal sinus. For example, U.S. Patent Application Publication No.2008-0097295 discloses a frontal sinus guide catheter (FIG. 6B) andmethod of treating the frontal sinuses (e.g., FIGS. 8B-8C). U.S. PatentApplication Publication No. 2008-0125626 discloses another guide device(e.g., FIGS. 10C and 10C′) for transnasal access to the frontal sinusesfor treatment.

SUMMARY OF THE INVENTION

In one embodiment, a method is disclosed of treating a sinus cavity of asubject using a balloon dilation catheter having a substantially rigidinner guide member and a movable shaft coupled to a balloon that isslidably mounted on the substantially rigid inner guide member. Themethod includes positioning a distal tip of the substantially rigidinner guide member behind an uncinate process; directing the distal tipalong a lateral side of the uncinate process until the distal tip ispositioned behind a lower aspect of the uncinate process; directing thedistal tip into a maxillary sinus ostium; advancing the shaft andballoon in a distal direction over the substantially rigid inner guidemember to place the balloon across the maxillary sinus ostium; andinflating the balloon.

In another embodiment, a method is disclosed of dilating an ethmoidalinfundibulum of a subject using a balloon dilation catheter having asubstantially rigid inner guide member and a movable shaft coupled to aballoon that is slidably mounted on the substantially rigid inner guidemember. The method includes positioning a distal tip of thesubstantially rigid inner guide member behind an uncinate process at afirst location within the ethmoidal infundibulum; advancing the shaftand balloon in a distal direction over the substantially rigid innerguide member to place at least a portion of the balloon within theethmoidal infundibulum; and inflating the balloon.

In another embodiment of the invention, a balloon dilation catheterincludes a substantially rigid inner guide member and a movable shaftcoupled to a balloon that is slidably mounted on the substantially rigidinner guide member. To treat a drainage pathway of a sinus cavity (e.g.,frontal sinus cavity) of a subject using the balloon dilation catheter,the substantially rigid inner guide member is advanced into a drainagepathway of the subject via a nasal passageway. The shaft and balloon arethen advanced in a distal direction over the substantially rigid innerguide member to place the balloon in the drainage pathway. This enablesthe balloon to track over the inner guide member. The balloon isinflated to expand or otherwise remodel the drainage pathway. Where thesinus cavity is the frontal sinus cavity the drainage pathway is thefrontal recess.

In another aspect of the invention, a device for dilating the outflowtract of a sinus cavity includes a substantially rigid inner guidemember having a proximal end and a distal end and a shaft coupled to aballoon, the shaft having a first lumen along at least a portion thereofcontaining the substantially rigid inner guide member, the shaft havinga second lumen operatively coupled to the interior of the balloon. Ahandle is disposed along a proximal portion of the substantially rigidinner guide member, the handle including a moveable knob operativelycoupled to the shaft, wherein distal advancement of the knob advancesthe shaft and balloon over the substantially rigid inner guide in adistal direction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a balloon dilation catheteraccording to one embodiment.

FIG. 2A illustrates a side view of a balloon dilation catheter ofFIG. 1. The advancer knob is illustrated in the retracted, proximalposition.

FIG. 2B illustrates a cross-sectional view of the balloon dilationcatheter of FIG. 2A.

FIG. 3A illustrates a side view of a balloon dilation catheter ofFIG. 1. The advancer knob is illustrated in the advanced, distalposition.

FIG. 3B illustrates a cross-sectional view of the balloon dilationcatheter of FIG. 3A.

FIG. 4 is a cross-sectional view of the handle portion (dashed lineportion) of FIG. 3B.

FIG. 5A is a cross-sectional view of the balloon dilation catheter takenalong the line A-A′ of FIG. 2B.

FIG. 5B is a cross-sectional view of the balloon dilation catheter takenalong the line B-B′ of FIG. 4.

FIG. 6A is a side view of an inner guide member according to oneembodiment.

FIG. 6B is a side view of an inner guide member according to anotherembodiment.

FIG. 6C is a side view of an inner guide member according to anotherembodiment.

FIG. 7 illustrates a perspective view of a balloon dilation catheteraccording to another embodiment.

FIG. 8 illustrates a cross-sectional view of the frontal sinus of asubject with the inner guide member of the balloon dilation catheterbeing advanced into the subject's frontal recess.

FIG. 9 illustrates a cross-sectional view of the frontal sinus of asubject with the inner guide member of the balloon dilation catheterbeing positioned in the subject's frontal recess. A guide wire is shownadvanced through the catheter and into the subject's frontal sinuscavity.

FIG. 10 illustrates a cross-sectional view of the frontal sinus of asubject with the balloon (in a deflated state) and shaft being advancedinto the subject's frontal recess.

FIG. 11 illustrates a cross-sectional view of the frontal sinus of asubject with the balloon of FIG. 10 in an inflated state to therebywiden and remodel the frontal recess.

FIG. 12 illustrates a cross-sectional view of the frontal sinus of asubject after the frontal sinus has been widened and the ballooninflation catheter withdrawn.

FIGS. 13A-13E illustrate various perspective and exploded views of oneembodiment of the invention.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIG. 1 illustrates one embodiment of a balloon dilation catheter 10 thatis particularly suited for treatment of the outflow tract (frontal sinusostium and frontal recess) of the frontal sinus of a subject. Theballoon dilation catheter 10 includes a handle 12 that is configured tobe gripped or otherwise manipulated by the operator. An elongate-shapedinner guide member 14 extends longitudinally from the handle 12 in adistal direction. The inner guide member 14 is formed of a suitablyrigid material such as stainless steel hypotube. The inner guide member14 projects or otherwise extends distally from the handle 12 for apre-determined distance. The inner guide member 14 may be pre-shaped tohave a curved distal portion 16 as is illustrated in FIGS. 1, 2A, 2B,3A, 3B, 6A, 6B, 7, 8, and 9. For example, the nature and degree of thecurved distal portion 16 may be configured to match with the frontalsinus outflow tract or frontal recess.

Alternatively, the inner guide member 14 may have some degree ofmalleability such that the user may bend or impart some desired shape orconfiguration to the distal end of the inner guide member 14. Asexplained herein in more detail, the inner guide member 14 may includean optional lumen 18 (best illustrated in FIG. 5A) that extends thelength of the inner guide member 14. In particular, the inner guidemember 14 and the contained lumen 18 may extend from a distal end 20 toa proximal end 21 (best seen in FIGS. 2B and 3B) that interfaces with asealed arrangement with a port 22 disposed at a proximal end 24 of thehandle 12. The port 22 may be configured with a conventional interfacesuch as a Luer connector. The port 22 may be used as an aspiration portor a delivery port for fluids and/or medicaments, or for introduction ofa guide wire.

Still referring to FIG. 1, a shaft 30 is mounted about the periphery ofthe inner guide member 14. In particular, the shaft 30 is dimensioned toslide over the inner guide member 14 in response to actuation of anadvancer knob 32 located on the handle 12. The advancer knob 32 ismoveable along a slot 42 contained in a surface of the handle 12. Adistal end 34 of the shaft 30 includes a balloon 36 that is configuredto be selectively inflated or deflated as explained herein. During use,the inner guide member 14 is manipulated and advanced across or into theanatomical space of interest. The shaft 30 as well as the attachedballoon 36 is illustrated in a retracted state in FIG. 1. While FIG. 1illustrates the balloon 36 in an inflated state for better illustration,the balloon 36 is typically in a deflated state when the shaft 30 is inthe proximal position as illustrated in FIGS. 2A and 2B. After the innerguide member 14 is properly positioned, the user actuates the advancerknob 32 by sliding the same in the distal direction which, in turn,advances the shaft 30 and balloon 36 in a distal direction over thepre-placed inner guide member 14. Once the balloon 36 is properlyplaced, the balloon 36 is inflated. Inflation of the balloon 36 isaccomplished using an inflation device (not shown) that is coupled to aport 38 located at the proximal end 24 of the handle 12. One exemplaryinflation device that may be used in connection with the balloondilation catheter 10 is described in U.S. Patent Application PublicationNo. 2010-0211007, which is incorporated by reference as if set forthfully herein. Of course, other inflation devices may also be used. Aninflation lumen 48 contained within the shaft 30 (described in moredetail below), fluidically couples the port 38 to an interior portion ofthe balloon 36.

Still referring to FIG. 1, an optional support member 40 in the form ofa tube may be located about the external periphery of a portion of theshaft 30 to impart further stiffness to the balloon dilation catheter10. The particular length of the support member 40 may vary depending onthe application and may extend along some or all or the shaft 30. Thesupport member 40 may be made of a metallic material such as stainlesssteel hypotube that is secured to the shaft 30. The support member 40may be welded or bonded along a length of the shaft 30. Generally, thesupport member 40 does not cover the helical portion (described indetail below) of the shaft 30 that is contained within the handle 12.

FIGS. 2A and 2B illustrate, respectively, side and cross-sectional viewsof the balloon dilation catheter 10 with the advancer knob 32 and thusballoon 36 in the proximal position. In actual use, as explained herein,the balloon 36 is typically in a deflated state when the advancer knob32 is the proximal position as illustrated in FIGS. 2A and 2B. As bestseen in FIG. 1, the advancer knob 32 is slidably disposed along a lengthof the handle 12 inside a slot 42. The advancer knob 32 is thus able toslide back and forth in the distal/proximal direction along the lengthof the slot 42. The slot 42 may incorporate a stop or the like (notshown) to prevent the balloon 36 from being advance too far along thelength of the inner guide member 14. The length of the slot 42 may bevaried in different devices to adjust the length at which the balloon 36may be advanced. Generally, the slot 42 has a length within the range ofabout 1 inch to about 2 inches although other dimensions may fall withinthe scope of the invention.

As seen in FIG. 2B, the advancer knob 32 may be directly coupled to thesupport member 40 that is mounted on the shaft 30. Alternatively, theadvancer knob 32 may be coupled directly to the shaft 30. The advancerknob 32 may be configured or otherwise shaped to enable a finger of theuser (e.g., index finger or thumb) to easily advance or retract the knob32 along the slot 42 contained in the handle 12.

FIGS. 3A and 3B illustrate, respectively, side and cross-sectional viewsof the balloon dilation catheter 10 with the advancer knob 32 and thusballoon 36 in the distal position. Thus, unlike the configurations ofFIGS. 2A and 2B, the advancer knob 32 is located at or near the distalend 26 of the handle 12. Advancement of the advancer knob 32 also slidesthe shaft 30 and attached balloon 36 in a distal direction (arrow A inFIG. 3A) along the inner guide member 14. The balloon 36 thus ispositioned at or adjacent to the distal end 20 of the inner guide member14. The balloon dilation catheter 10 may be designed such that theadvancer knob 32 may be positioned at either the proximal or distalextremes as illustrated in FIGS. 2A, 2B, 3A, 3B. Alternatively, theadvancer knob 32 may be positioned somewhere in between the twoextremes. For example, the optimal position of the balloon 36 may beaccomplished by sliding the advancer knob 32 some fraction (e.g., ¾) ofthe full distance of the slot 42.

Referring to FIGS. 2B and 3B, the inner guide member 14 of the balloondilation catheter 10 extends from a distal end 20 to a proximal end 21that terminates in a sealed interface with a port 22 disposed at aproximal end 24 of the handle 12. The inner guide member 14 optionallyincludes a lumen 18 disposed therein that may be used to provideaspiration functionality via an aspiration device (not shown) coupled toport 22. Aspiration functionality permits the removal of blood and othersecretions. This makes it easier to visualize the placement of theballoon dilation catheter 10. The inner guide member 14 isadvantageously rigid to enable the balloon dilation catheter 10 to bepositioned without the need of a separate guiding catheter or guide wirein most, if not all, instances.

The inner guide member 14 may have a length of about 7 inches to about11 inches from the distal end 20 to the proximal end 21 when loaded intothe handle 12, although other dimensions may be used. The inner guidemember 14 may be formed from stainless steel hypotube having an innerdiameter in the range of about 0.020 inch to about 0.050 inch, and morepreferably between about 0.036 inch and 0.040 inch, with a wallthickness within the range of about 0.005 inch to about 0.020 inch, andmore preferably between about 0.008 inch to about 0.012 inch. The curveddistal portion 16 of the inner guide member 14 may be formed right tothe distal end 20 and may have a radius of curvature of about 0.25 inchto about 1.5 inch, and more preferably about 0.75 to about 1.25 inch.

The length of the inner guide member 14 that projects distally from thedistal-most portion of the balloon 36 is about 0.5 inch to about 2.0inch, and more preferably, about 0.8 inch to about 1.2 inch when theballoon 36 is in the fully retracted state (e.g., illustrated in FIGS.2A and 2B). As seen in FIGS. 1, 2A, 2B, 3A, 3B, 6A-6C, 7-11, the distalend 20 of the inner guide member 14 may incorporate an optional bulboustip 44 in order to make the distal end 20 more atraumatic. The bulboustip 44 further serves to limit forward movement of the balloon 36 andattached shaft 30 when they are advanced distally. The outer diameter ofthe tip 44 is preferably between about 1 mm and about 3 mm.

The balloon 36 is mounted on the shaft 30 so as to form a fluidic sealbetween the two components. The balloon 36 may be bonded to the shaftusing a weld, adhesive, or the like. Alternately, the balloon 36 may besecured to the shaft using a mechanical connection. Generally, anytechnique known to those skilled in the art may be used to secure to theballoon 36 to the shaft 30. Given that the balloon 36 is secureddirectly to the shaft 30, both structures are slidably mounted over theinner guide member 14. The balloon 36 generally takes on acylindrical-shape when inflated. While not limited to specificdimensions, the inflated balloon 36 has a diameter within the range ofabout 3 mm to about 9 mm, and more preferably a diameter within therange of about 5 to about 7 mm when inflated. The length of the balloon36 may generally fall within the range of about 10 mm to 25 mm althoughother lengths may be used. Both the shaft 30 and the balloon 36 arepreferably formed of high strength but flexible polymeric materials suchas polyamides (e.g., Nylon), PEBAX or the like. The balloon 36 may be“blow molded” to a relatively thin wall thickness, and capable ofholding relatively high pressures from about 6 atmospheres to about 20atmospheres of inflation pressure. The balloon 36 is inflated using afluid which is typically a liquid such as water or saline.

Referring now to FIG. 4, a magnified, cross-sectional view of a portionof the handle 12 is illustrated. At the proximal end 24 of the handle 12are located ports 22, 38. The port 22 may be configured with aconventional interface such as a Luer connector or any other connectorknown to those skilled in the art. The port 22 may be integrally formedwith the handle 12 or, alternatively, the port 22 may be a separatestructure that is secured to the handle 12 during assembly. As seen inFIG. 4, the proximal end 21 of the inner guide member 14 forms a sealingarrangement with the port 22. As explained herein, the port 22 may beused as an aspiration port or a delivery port for fluids and/ormedicaments.

FIG. 4 also illustrates port 38 which may be constructed in the same orsimilar manner as port 22 as described above. The port 38 is fluidicallycoupled to the inflation lumen 48 in the shaft 30. In this regard,inflation fluid from an inflation device (not shown) is able to passthrough the port 38 and into the inflation lumen 48 of the shaft 30. Theport 38 may be configured with a conventional interface such as a Luerconnector. The fluid then is able to travel along the length of theshaft 30 via the lumen 48 where the fluid enters the interior of theballoon 36. The inflation fluid is thus able to inflate the balloon 36upon actuation of the inflation device.

As best seen in FIG. 4, a portion of the handle 12 includes a recessedregion 50 that receives both the inner guide member 14 and the shaft 30.In the recessed region 50 of the handle 12, the shaft 30 is helicallywrapped around the outer periphery of the inner guide member 14 forminga helical portion 52. The helical portion 52 facilitates the distaladvancement and proximal retraction of the shaft 30 and attached balloon36 along the inner guide member 14 yet still maintains fluidcommunication with the port 38. The helical portion 52 of the shaft 30,which is located proximal to the advancer knob 32 is in the shape of ahelix that wraps around the inner guide member 14 and is configured toelongate and contract upon movement of the advancer knob 32. FIG. 4illustrates the state of the helical portion 52 after the advancer knob32 has been advanced distally. Thus, in the extended state, the lengthof the helical portion 52 traverses much if not all of the recessedregion 50. Contrast this with FIG. 2B which illustrates the helicalportion 52 compressed to the proximal portion of the recessed region 50because the advancer knob 32 is the in proximal position. Thus, thehelical portion 52 is thus able to expand or compress much in the waythat a spring does in response to a tensile or compressive load. One orboth of the inner guide member 14 and the helical portion 52 of theshaft 30 may be optionally coated or lined with a lubricious coating toprevent the contact surfaces from any unwanted frictional binding or thelike.

The helical portion 52 of the shaft 30 may be formed by “skiving” away aportion of the shaft 30. FIG. 5A illustrates a cross-sectional view ofthe shaft 30, inner support guide 14, and support member 40 along theline A-A′ of FIG. 2B. As seen in FIG. 2B, this area is distal to wherethe helical portion 52 of the shaft 30 is located. Referring now to FIG.5A, the shaft 30 includes a rider lumen 54 that is dimensioned to have adiameter that is slightly larger than the outer diameter of the innersupport guide 14. The rider lumen 54 thus enables the shaft 30 toadvance and retract over the inner support guide 14 in a close-fitarrangement. The outer diameter of the shaft 30 may generally fallwithin the range of about 0.050 inch to about 0.110 inch or within therange of about 0.070 inch to about 0.100 inch. One or both of theexterior surface of the inner guide member 14 and the interior surfaceof the rider lumen 54 may be optionally coated with a lubricious coatingto reduce frictional contact forces. FIG. 5B illustrates across-sectional view of the inner support guide 14 and the helicalportion 52 of the shaft 30 taken along the line B-B′ of FIG. 4. As seenin FIG. 5B, a portion of the shaft 30 that includes the rider lumen 54is skived away. The result is that a single lumen (inflation lumen 48)remains in the shaft 30 that is helically wrapped about the innersupport guide 14.

FIGS. 6A-6C illustrate various embodiments of an inner guide member 14.The inner guide member 14 may have a variety of shapes andconfigurations depending on the particular application or patient. Thedifferent shapes of the inner guide member 14 may be factory-formed in aparticular shape and offered as a different model as fully assembled or,alternatively, the inner guide member 14 may be replaceable or modularelements that could slide inside the rider lumen 54 and inserted intothe port 22 in a press-fit type sealing arrangement. In yet anotheralternative, the shapes could represent desirable shapes that amalleable inner guide member 14 could be formed into by the user tobetter fit a particular application or subject's anatomy.

FIG. 6A illustrates an inner guide member 14 that includes a curveddistal portion 16 that terminates in a straight segment 46. In theembodiment of FIG. 6A, the curve in the curved distal portion 16 ispronounced and turns back on itself in the shape of a “U” in which thedistal end 20 turns back in retrograde fashion. This embodiment may beuseful to treat hard to reach ostia or other structures, e.g., themaxillary ostium or the infundibulum via a transnasal route, if thenasal anatomy will allow for a transnasal approach. While FIG. 6Aillustrates a “U” shaped curve, other degrees of curvature arecontemplated. FIG. 6B illustrates an inner guide member 14 according toanother embodiment. In this embodiment, the curved distal portion 16also terminates in a straight segment 46 although the radius ofcurvature is less pronounced. In this embodiment, the straight segment46 may have a length within the range of about 8 mm to about 10 mmalthough other lengths may be used. For example, there may be a distalleg or straight segment 46 leg that is between about 10 and about 12millimeters in length that extends from the curved portion. It isbelieved that this embodiment is particularly suited for most frontalrecess anatomy. FIG. 6C illustrates an embodiment in which the innerguide member 14 is substantially straight. This later embodiment may beparticularly suited for treating the sphenoids of the subject, orstraightforward frontal recess anatomy.

FIG. 7 illustrates a balloon dilation catheter 10 according to anotherembodiment. In this embodiment, a tracking element 60 is located on thehandle 12 of the balloon dilation catheter 10. The tracking element 60may include an antenna, transmitter, optical reflectors, or the likethat communicates a wireless signal that is then received and processedto determine the orientation and/or positioning of the balloon dilationcatheter 10. In certain embodiments, more than one tracking element 60may be disposed on the balloon dilation catheter 10. Data regarding theorientation and/or positioning of the balloon dilation catheter 10 maythen be processed and displayed on the display for viewing by thephysician. For example, image guided surgery is becoming increasinglycommonplace, permitting physicians to review real time actual or virtualimages of a particular device within a subject during a surgicalprocedure.

For example, U.S. Pat. Nos. 5,391,199 and 5,443,489, which areincorporated by reference, describe a system wherein coordinates of anintrabody probe are determined using one or more field sensors such as,Hall effect devices, coils, or antennas that are carried on the probe.U.S. Patent Application Publication No. 2002-0065455, which is alsoincorporated by reference, describes a system that is capable ofgenerating a six-dimensional position and orientation representation ofthe tip of a catheter using a combination of sensor and radiation coils.U.S. Patent Application Publication No. 2008-0269596, which is alsoincorporated by reference, describes yet another monitoring system thathas particular applications in orthopedic procedures. Commercial systemssuch as the LANDMARX Element (Medtronic Xomed Products, Inc.,Jacksonville, Fla.) are available for use in conjunction with ENTprocedures.

In the embodiment of FIG. 7, the tracking element 60 permits accuratetracking of the distal end 20 of the balloon dilation catheter 10 suchthat an image of distal portion of the balloon dilation catheter 10 maybe superimposed on a patient's anatomical imagery. For example, apreviously conducted computed tomography (CT) scan of the patient may beused to generate a visual image of the patient's anatomical regions ofinterest. Based on the location of the tracking element 60, an imageguided surgery (IGS) system can then superimpose an image of the balloondilation catheter 10 onto the image to better enable the physician tomanipulate and orient the balloon dilation catheter 10.

Other commercial systems may also be used in connection with the balloondilation catheter 10 illustrated in FIG. 7. For example, the INSTATRAK3500 Plus-ENT from GE Healthcare, Chalfont St. Giles, United Kingdom maybe integrated and/or used with the balloon dilation catheter 10. The useof CT guidance to position the balloon dilation catheter 10 is preferredbecause the device may be positioned by the operator with just a singlehand, while viewing the CT image interface (e.g., display) at the sametime the handle 12 is manipulated. Optionally, the balloon dilationcatheter 10 may be initially positioned using and endoscope or othervisualization tool. For instance, a conventional “Hopkins rod” endoscope(not shown) may be manipulated alongside the balloon dilation catheter10 to aid in placement.

FIGS. 8-12 illustrate various cross-sectional views (sagittal plane) ofthe frontal sinus of a subject undergoing treatment with a balloondilation catheter 10. The cross-sectional views illustrate the nasalpassageway 100, the frontal recess 102, and the frontal sinus cavity104. Referring to FIG. 8, the balloon dilation catheter 10 is insertedinto the nasal passageway 100 with the advancer knob 32 in the retractedposition (e.g., as illustrated in FIG. 1, 2A, 2B) such that the shaft 30and balloon 36 are also retracted proximally. In addition, the balloon36 is in a deflated state as seen in FIG. 8. The curved portion 16 ofthe inner guide member 14 is then positioned within the frontal recess102 of the subject as seen in FIG. 8. This positioning of the innerguide member 14 may be accomplished under endoscopic visualization usinga conventional endoscope such as a Hopkins rod-type endoscope that ispositioned alongside the balloon dilation catheter 10. Alternatively,the inner guide member 14 may be positioned using IGS techniques thattrack the position of the balloon dilation catheter 10 using one or moretracking elements 60 as illustrated, for instance, in the embodiment ofFIG. 7. For instance, the inner guide member 14 may be advanced underguidance from CT imaging.

Referring now to FIG. 9, confirmation of accurate positioning of theinner guide member 14 within the frontal recess 102 may be accomplishedby placement of a fluoroscopically visible guide wire 64 through thelumen 18 of the inner guide member 14. The guide wire 64 may be insertedinto the lumen 18 via the port 22. Under fluoroscopic visualization, theguide wire 64 can be seen to advance into the frontal sinus cavity 104once the inner guide member 14 is positioned properly within the frontalrecess 102. If the guide wire 64 does not advance into the frontal sinuscavity 104, the balloon dilation catheter 10 is re-positioned andconfirmation is subsequently attempted. As an alternative to afluoroscopically visible guide wire 64, the guide wire 64 could be alight emitting guide wire such as that disclosed in U.S. PatentApplication Publication No. 2007-0249896, which is incorporated byreference herein. Of course, the guide wire 64 is optional as the innerguide member 14 may be placed without the aid or need for the same.Alternatively, the guide wire 64 could be positioned in the frontalsinus initially, prior to placement of the balloon catheter 10.

Now referring to FIG. 10, once the curved portion 16 of the inner guidemember 14 is properly positioned, the advancer knob 32 is advanced inthe distal direction (arrow A of FIG. 3A) thereby advancing the shaft 30and attached balloon 36 into the frontal recess 102. This is illustratedin FIG. 10. After the balloon 36 is positioned in the frontal recess102, the balloon 36 is inflated as illustrated in FIG. 11. Inflation isaccomplished by coupling an inflation device (not shown) to the port 38.The inflation device may include a syringe or the like that is depressedto infuse a fluid into the inflation lumen 48 which then passes into theinterior of the balloon 36 to effectuate expansion of the balloon 36 tothe state illustrated in FIG. 11. Pressures typically used to accomplishwidening or remodeling of the frontal recess 102 are within the range ofabout 3 atmospheres to about 12 atmospheres. The balloon 36 may beinflated only a single time or, alternatively, the balloon 36 may beinflated, deflated, and inflated again a plurality of times in order toachieve the desired degree of widening. Each inflation step may beperformed after positioning the balloon 36 in a different positionwithin the frontal recess 102.

After the frontal recess 102 has been widened or otherwise remodeled,the balloon 36 is deflated and removed as illustrated in FIG. 12. Thewidened frontal recess 102 illustrated in FIG. 12 is believed to restorethe drainage and aeration function and health of the frontal sinuscavity 104. Deflation of the balloon 36 is accomplished by reducing thefluid pressure within the interior of the balloon 36. For example, theplunger of a syringe or the like that is fluidically coupled to the port38 may be withdrawn to remove fluid from the interior of the balloon 36.The balloon dilation catheter 10 can then be withdrawn proximally fromthe nasal passageway 100.

In certain patients, treatment of one or both frontal sinuses 104 asdescribed above may be adequate. In other patients, additional sinusesmay need to be treated, particularly the maxillary and/or anteriorethmoid sinuses. In such patients, a combination procedure may be wellsuited. The maxillary and/or anterior ethmoid sinuses can be treatedwith a system such as described in U.S. Pat. No. 7,520,876 and U.S.Patent Application Publication No. 2008-0172033, commercially availableas the FinESS system by Entellus Medical, Inc. of Maple Grove, Minn.Alternatively, other sinuses could be treated more conventionally usingsurgical techniques such as, for instance, functional endoscopic sinussurgery (FESS).

Also, the sphenoid and/or maxillary sinus outflow tracts could bedilated with the embodiments of the balloon catheter 10 describedherein. It is also contemplated that the balloon catheter 10,particularly the embodiment of FIG. 7 with a suitable IGS device isincorporated, and with an appropriate shape for the inner support member14, preferably straight as illustrated in FIG. 6C, could be used todilate the maxillary sinus outflow tract via the canine fossa route.Suitable access tools are described in co-pending U.S. PatentApplication Publication No. 2009-0216196, which is incorporated byreference herein. This could be performed without need for additionalendoscopic visualization, permitting treatment through a relativelysmall diameter access passageway into the sinus cavity in the region ofthe canine fossa. A small endoscope (not shown) could be utilized, ifdesired, through the lumen 18 of the inner support member 14 to furtheraid in visualization of the maxillary sinus outflow tract.

Of course, the balloon catheter 10 described herein may be used todilate the maxillary sinus ostia via a transnasal route as well. Forexample, a balloon catheter 10 such as that illustrated in FIGS. 1, 2A,2B, 3A, 3B, 7, 13A, 13B, 13C, 13D may be used.

In one aspect of the invention, the balloon dilation catheter used forsinus dilation includes an inner guide member that terminates in amalleable distal tip. The malleable distal tip may include an atraumaticball tip (e.g., around 2 mm in diameter). The distal tip of the innerguide member may be placed at a desired anatomical location and a shaftcoupled to a dilation balloon can then be advanced along the inner guidemember to selectively place the balloon along or within the location. Insome embodiments, the balloon dilation catheter includes illuminationfunctionality at the distal tip of the device. For example, one or morelight fibers may traverse along all or a portion of the balloon dilationcatheter. The one or more light fibers may direct light from a proximalend of the balloon dilation catheter out through the distal tip of thetool. The light may be used to aid in direct visualization of anatomicalfeatures of the sinus cavity or sinus drainage pathway or to confirm alocation within the nasal or sinus system. For example, in addition toor as an alternative to direct visualization, light emitted from thedistal end of the tool may be used for transillumination purposes to,for example, confirm the positioning of the distal tip within aparticular sinus cavity (e.g., maxillary sinus).

The one or more light fibers may be secured to the dilation catheter or,alternatively, the one or more light fibers may be removably securedwithin the dilation catheter such that the one or more light fibers canbe removed from the tool at some point during use. The one or more lightfibers may terminate substantially at or adjacent to the atraumatic balltip. In other embodiments, the one or more light fibers may themselvesinclude an atraumatic tip (e.g., spherical ball tip). Details regardingvarious configurations of a dilation catheter with light fiberfunctionality can be found in U.S. Patent Application Publication No.2012-0071727, which is incorporated by reference herein.

In one aspect, a single dilation catheter can be used to dilate multiplesinus drainage pathways. When features of the maxillary sinus are to bedilated in conjunction with other sinus features, it is preferable totreat the maxillary sinus after the other sinuses have been treated.

After treating other sinuses, the malleable distal tip of a dilationcatheter (optionally with a light fiber functionality) is bent using abending tool. A bend of approximately 135° with a 10-12 mm leg isgenerally recommended when treating the maxillary ostia/ethmoidinfundibula to gain access to the natural maxillary ostium, though smalladjustments to the bend may be considered to accommodate differentpatient anatomy. After the distal portion of the device is bent, andprior to insertion into the nose, the balloon is fully advanced forwardto the ball tip so that the physician will know the degree of forcegenerally required for balloon advancement. Moreover, such advancementalso pre-conditions the balloon shaft to more easily advance around thebend in the distal end of the inner guide member.

Optionally, a separate maxillary seeker can be used to cannulate theostium before the dilation catheter is inserted into the nasal cavity.Cannulating the maxillary ostium with a separate seeker can provide thephysician with a visual reference of the angle and position that thedilation catheter will take when it is subsequently inserted into theostium. Cannulating the maxillary ostium with a separate seeker may alsoincrease the infundibular width, making it easier to later position theatraumatic ball tip of the dilation catheter behind the uncinateprocess.

Maxillary ostia are typically found in the lower aspect of the uncinateprocess, usually behind the lowest fifth of the uncinate process. So thedistal tip of the inner guide member should be positioned behind thislower aspect of the uncinate process. The distal tip may be insertedinto nasal anatomy in either a “tip up” or “tip down” orientation,depending upon the particulars of the patient's anatomy. If a large bulais present, a “tip up” orientation may be more easily inserted behindthe uncinate process. If rotation of the ball tip is difficult, it maybe necessary to first dilate the infundibulum with the balloon from thedilation catheter. If infundibular dilation is needed prior toattempting to cannulate the maxillary ostium, the distal tip of theinner guide member is advanced behind the uncinate process and theballoon is advanced and dilated. This can be done at the inferior orsuperior aspect of the uncinate and infundibulum—or at both locations byrepositioning of the balloon at the different locations. This dilationof the infundibulum can be useful for increasing the working space sothat the distal tip of the inner guide member can be more easily rotatedinto position to cannulate the natural maxillary ostium.

When using the dilation catheter itself to cannulate the ostium, it isimportant to avoid the fontanelle. One way to accomplish this is toguide the distal tip of the inner guide along the lateral side of theuncinate process to both avoid the fontanelle and guide the distal tipdirectionally toward the maxillary ostium. While doing so, the physiciancan visualize the ball tip of the inner guide slightly deflecting theuncinate medially (antero-medially). It should be noted again that theball tip should be positioned behind the lower aspect of the uncinateprocess (typically in the lowest ˜20% of the uncinate process). Thisprocess of riding the distal tip of the inner guide along the lateralside of the uncinate process may be done with or without illumination oflight from the distal tip of the dilation catheter. Illumination maybetter aid in visualizing the ball in contact with the uncinate. Thelight may also be used to transilluminate the uncinate process to verifythat the ball tip is in contact with the back side of the uncinate andto show the physician the location of the ball tip during cannulation ofthe ostium.

If the 135° bend in the distal tip of the inner guide prevents the balltip from being placed behind the uncinate process, it may be helpful toreshape the distal portion of the inner guide to decrease the angle ofthe bend slightly. This will often be a bend of around 115° to around125°. After making the adjustment, the ball tip of the dilation cathetercan then be guided along the back side of the uncinate process to ensurethat the ball tip does not penetrate the posterior fontanelle.

After the ostium has been found, the handle of the dilation catheter maybe pulled anteriorly and inferiorly before inflation such that theuncinate process is deflected with a “v” notch formed in the upper lipof the uncinate at the point of contact with the inner guide member ofthe dilation catheter. Once the balloon is advanced and in place withinthe natural ostium, the balloon is inflated. Before and duringinflation, the handle may be pulled anteriorly and inferiorly to ensurethat the balloon is fully into the ostium. In addition, the advancerknob or slide may be fully advanced in the distal direction andmaintained in that advanced state during inflation to ensure that theballoon does not move backward on the inner guide member duringinflation. After the initial dilation of the maxillary ostium, theexpanded infundibular width may be used to seat the ball tip furtherinto the maxillary ostium and a second dilation may optionally beperformed. After the desired dilations, the balloon is deflated andretracted proximally from the maxillary drainage pathway. Optionally,the superior portion of the uncinate and infundibulum may be dilatedafter the ostium has been dilated. In some embodiments, the inventionincludes a surgical procedure where the uncinate and infundibulum aredilated with one of the balloon catheters of the invention, but theassociated maxillary ostium is not dilated.

FIGS. 13A-13E illustrate another embodiment of the present inventionthat includes balloon dilation catheter 1310. Catheter 1310 is similarto previous embodiments of the invention and includes handle 1312, innerguide member 1314 (which defines a lumen extending from port 1322 to itsdistal end 1326), shaft 1330, and balloon 1336. Catheter 1310 also,however, includes suction vent port 1370 that allows a user of thisembodiment to control suction applied by distal end 1320 of inner guidemember 1314. FIG. 13B illustrates an exploded view of catheter 1310showing vent tube 1371 and valve seat 1372. FIG. 13C illustrates acut-away view of handle 1312 of catheter 1310. FIG. 13D illustrates anexploded view of catheter 1310 that omits inner guide member 1314 forclarity. FIG. 13E illustrate an exploded view of just vent tube 1371 andvalve seat 1372.

Tube 1371 and seat 1372 are situated within an interior space defined byhandle 1312 and are in fluid communication with vent port 1370 and thelumen defined by inner guide member 1314. Hence, vent port 1370, tube1371, seat 1372, the lumen defined by inner guide member 1314, distalend 1320 of inner guide member 1314, and port 1322 are all in fluidcommunication with one another. When a user of catheter 1310 attaches avacuum source to port 1322, a suction force will be produced at each ofthe distal end 1320 and vent port 1370. During use, when a vacuum sourceis attached to port 1322, a user of catheter 1310 can use a singlefinger to occlude or block vent port 1370 in order to increase theamount of suction at distal end 1320 of inner guide member 1314.Removing the finger from vent port 1370 will increase the amount ofsuction at vent port 1370 while reducing the amount of suction at distalend 1320 of inner guide member 1314. In this way, a user can use asingle hand to manipulate catheter 1310, control the amount of suctionproduced at distal end 1320 of inner guide member 1314, and advance aballoon (like previous embodiments, balloon 1336 and shaft 1330 can beadvanced along inner guide member 1314 using advancer knob 1332). Valve1373 prevents aspirate collected at distal end 1320 from entering tube1371 and seat 1372.

Catheter 1310 also includes inflation lumen 1348, as best illustrated inFIGS. 13B, 13C, and 13D. Similar to the previously describedembodiments, inflation lumen 1348 provides a fluid channel betweeninflation port 1338 and the interior of balloon 1336 through which aninflation medium can be directed. The inflation lumen of catheter 1310does not include a helical portion wrapped about an inner guide member,but instead has portion 1352 that is looped or folded back upon itself.The looped portion 1352 provides sufficient slack in inflation lumen1348 so that balloon 1336 can be advanced along inner guide 1314 whilekeeping balloon 1336 in fluid communication with inflation portion 1338.

While embodiments of the present invention have been shown anddescribed, various modifications may be made without departing from thescope of the present invention. The invention, therefore, should not belimited, except to the following claims, and their equivalents.

1-9. (canceled)
 10. A balloon dilation catheter, comprising: a handlehaving a proximal end and a distal end; an inner guide member thatextends distally from the distal end of the handle; a shaft slidablyarranged with respect to the inner guide member, wherein a distalportion of the shaft includes an inflatable balloon; a shaft advancingmember configured to move the shaft and the inflatable balloon along theinner guide member from a retracted state to an extended state; and aninflation lumen that defines a fluid channel between an inflation porton the handle and an interior of the inflatable balloon, wherein theinflation lumen comprises a looped portion that is configured to provideslack to the inflation lumen such that the inflatable balloon is movablebetween the retracted state and the extended state while maintaining theinflatable balloon in fluid communication with the inflation port. 11.The balloon dilation catheter of claim 10, wherein the looped portion ofthe inflation lumen is in an interior space defined by the handle. 12.The balloon dilation catheter of claim 11, wherein the inflation port isat a proximal end of the handle.
 13. The balloon dilation catheter ofclaim 10, wherein the inner guide member comprises a proximal portionthat is in the handle and a distal portion that extends distally fromthe distal end of the handle, wherein the distal portion of the innerguide member is pre-shaped to have a curved portion.
 14. The balloondilation catheter of claim 13, wherein a radius of curvature of thecurved portion is between about 0.75 inches and 1.25 inches.
 15. Theballoon dilation catheter of claim 13, wherein the distal portion of theinner guide member further comprises a straight segment that is distalof the curved portion.
 16. The balloon dilation catheter of claim 15,wherein the straight segment has a length that is between about 10 andabout 12 millimeters.
 17. The balloon dilation catheter of claim 10,wherein the handle comprises a vent port in fluid communication with alumen defined by the inner guide member.
 18. The balloon dilationcatheter of claim 17, wherein the shaft advancing member is moveablealong a slot in a surface of the handle, wherein the vent port isdisposed in the surface of the handle.
 19. The balloon dilation catheterof claim 10, wherein the shaft advancing member is directly coupled tothe shaft.
 20. The balloon dilation catheter of claim 10, wherein theinner guide member is formed from a stainless steel hypotube.
 21. Theballoon dilation catheter of claim 20, wherein the inner guide memberhas a wall thickness in a range of about 0.005 inches and about 0.020inches.
 22. The balloon dilation catheter of claim 10, wherein theballoon dilation catheter includes a stop that prevents the shaft fromadvancing past a predetermined position relative to the inner guidemember.
 23. The balloon dilation catheter of claim 22, wherein the stopcomprises a slot in which the shaft advancing member is moveable,wherein the slot has a length of about one inch to about two inches. 23.The balloon dilation catheter of claim 10, wherein the proximal end ofthe inner guide member is secured within the handle.
 25. The balloondilation catheter of claim 10, wherein the shaft is mounted about aperiphery of the inner guide member.
 26. The balloon dilation catheterof claim 25, wherein the inflatable balloon is disposed about the innerguide member.
 27. The balloon dilation catheter of claim 10, wherein theinner guide member comprises a lumen extending from a proximal end ofthe inner guide member to a distal end of the inner guide member. 28.The balloon dilation catheter of claim 10, further comprising a supportmember defining a tube that is disposed about a periphery of the shaft,wherein the support member has a length that extends along at least aportion of the shaft.
 29. A balloon dilation catheter, comprising: ahandle having a proximal end and a distal end; an inner guide memberthat extends distally from the distal end of the handle; a shaftslidably arranged with respect to the inner guide member, wherein adistal portion of the shaft includes an inflatable balloon; a shaftadvancing member coupled to the shaft; and an inflation lumen thatdefines a fluid channel between an inflation port on the handle and aninterior of the inflatable balloon, wherein the inflation lumencomprises a looped portion in an interior space defined by the handle.